Micro-needle and method of manufacture

Abstract

Disclosed is a microneedle including: a needle part including a plurality of tips formed from a liquid formulation formed with a medicinal solution and capable of penetrating the skin; and a base for supporting the plurality of tips; and a guide part configured to guide the needle part to penetrate the skin, wherein the needle part is provided with separation guides formed between the tips and the base to separate the tips from the base. According to such a configuration, the tips rapidly penetrate the skin and are rapidly separated therefrom, which allows quantitative drug delivery.

1 . A microneedle, comprising:
 a needle part comprising a plurality of tips formed from a liquid formulation formed with a medicinal solution and capable of penetrating the skin; and a base for supporting the plurality of tips; and   a guide part configured to guide the needle part to penetrate the skin,   wherein the needle part is provided with separation guides formed between the tips and the base to separate the tips from the base.   
     
     
         2 . The microneedle according to  claim 1 , wherein the guide part comprises a plurality of pressing protrusions respectively coupled to the tips; and a support supporting for the plurality of pressing protrusions,
 wherein the guide part is integrally formed with the needle part, and is separated from the tips after the tips penetrate the skin.   
     
     
         3 . The microneedle according to  claim 2 , wherein coupling grooves are provided at rear ends, coupled to the pressing protrusions, of the tips such that the plurality of pressing protrusions are respectively inserted thereinto,
 wherein the coupling grooves have a hemispherical shape of being grooved in the penetration direction toward front ends of the tips from rear ends thereof.   
     
     
         4 . The microneedle according to  claim 1 , wherein the guide part is separated from the tips along with the base when the tips penetrate the skin. 
     
     
         5 . The microneedle according to  claim 1 , wherein the separation guide is provided between each of the tips and the base and is thinner than the tip so that the tips are easily separated from the base due to physical pressing force by the guide part. 
     
     
         6 . The microneedle according to  claim 1 , wherein the separation guide comprises a plurality of separation holes formed between each of the tips and the base to be spaced apart from each other along the circumference of the tip, and a perforation line is formed along the plurality of separation holes along which the tips are respectively separated from the base. 
     
     
         7 . The microneedle according to  claim 3 , wherein the separation guide comprises a plurality of separation holes formed between each of the tips and the base to be spaced apart from each other along a circumference of the coupling groove, and a perforation line is formed along the plurality of separation holes along which the tips are respectively separated from the base. 
     
     
         8 . The microneedle according to  claim 1 , wherein the guide part comprises an adhesive band provided on a rear surface of the base with respect to a penetration direction of the needle part, wherein adhesive force between the adhesive band and the skin is greater than adhesive force between the adhesive band and the needle part. 
     
     
         9 . The microneedle according to  claim 8 , wherein a hemispherical cavity is provided in the penetration direction between each of the tips and the adhesive band. 
     
     
         10 . A method of manufacturing a microneedle, the method comprising:
 manufacturing a needle part that comprises a plurality of tips formed from a liquid formulation formed with a medicinal solution and a base for supporting the plurality of tips;   manufacturing a guide part configured to guide the needle part in a penetration direction in which the needle part penetrates the skin; and   coupling the guide part to the needle part such that the needle part is pressed in a direction in which the needle part penetrates the skin,   wherein the needle part is provided with a separation guide formed between each of the tips and a base to separate the tip from the base.   
     
     
         11 . The method according to  claim 10 , wherein, in the manufacturing of the needle part, a polymer solution corresponding to the liquid formulation is injected into a mold comprising mold grooves that correspond to the tips having a horn shape wherein a front end is pointed and a diameter increases toward a rear end with respect to a penetration direction in which the needle part penetrates the skin, followed by centrifugation and drying to be molded. 
     
     
         12 . The method according to  claim 11 , wherein the separation guide is provided to have a thinner thickness than each of the tips between the tip and the base, thereby serving to separate the tips from the base due to physical pressing force by the guide part. 
     
     
         13 . The method according to  claim 11 , wherein the separation guide comprises a plurality of separation holes that are provided to be spaced apart from each other between each of the tips and the base along a circumference of the tip to form a perforation line, and the mold comprises a plurality of mold projections that are formed to be spaced apart from each other along the circumferences of the mold grooves to form the separation holes. 
     
     
         14 . The method according to  claim 10 , wherein, in the manufacturing of the guide part, a plurality of pressing protrusions respectively corresponding to the tips; and a support for supporting the plurality of pressing protrusions are manufactured by molding, and coupling grooves are provided in the penetration direction such that the pressing protrusions are respectively inserted and coupled to rear ends of the tips. 
     
     
         15 . The method according to  claim 14 , wherein a height of the coupling groove is adjusted according to a ratio of a volume of the liquid formulation to a volume of the mold for a molding process; and a content of a solid formulation in the liquid formulation. 
     
     
         16 . The method according to  claim 10 , wherein the manufacturing of the guide part comprises:
 preparing for covering the base; and   adhering the adhesive band to a rear surface of the base with respect to a penetration direction of the needle part such that adhesive force between the adhesive band and the skin is greater than adhesive force between the adhesive band and the needle part.   
     
     
         17 . The method according to  claim 16 , wherein a hemispherical cavity is provided between each of the tips and the adhesive band. 
     
     
         18 . The method according to  claim 10 , wherein the liquid formulation is prepared by mixing a biocompatible material with a solvent, the biocompatible material comprising one or more selected from the group of consisting of hyaluronic acid, alginic acid, pectin, carrageenan, chondroitin (sulfate), dextran (sulfate), chitosan, polylysine, collagen, gelatin, carboxymethyl chitin, fibrin, agarose, pullulan polylactide, polyglycolide (PGA), polylactide-glycolide copolymers (PLGA), hyaluronic acid, alginic acid, carrageenan, chondroitin (sulfate), dextran (sulfate), chitosan, polylysine, collagen, gelatin, carboxymethyl chitin, fibrin, agarose, pullulan polyanhydride, polyorthoester, polyetherester, polycaprolactone, polyesteramide, poly(butyric acid), poly(valeric acid), polyurethane, polyacrylate, ethylene-vinyl acetate copolymers, acrylic-substituted cellulose acetate, non-degradable polyurethane, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulphonate polyolefins, polyethylene oxide, polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polymethacrylate, hydroxypropyl methylcellulose (HPMC), ethyl cellulose (EC), hydroxypropyl cellulose (HPC), carboxymethyl cellulose, cyclodextrin, and copolymers and cellulose of monomers forming the polymers. 
     
     
         19 . The method according to  claim 10 , wherein the liquid formulation is mixed with an additive for increasing mechanical strength, the additive being formed of one or more materials selected from the group consisting of trehalose, glucose, maltose, lactose, lactulose, fructose, turanose, melitose, melezitose, dextran, sorbitol, xylitol, palatinit, mannitol, poly(lactide), poly(glycolide), poly((lactide-co-glycolide), polyanhydride, polyorthoester, polyetherester, polycaprolactone, polyesteramide, poly(butyric acid), poly(valeric acid), polyurethane, polyacrylate, ethylene-vinyl acetate copolymers, acrylic-substituted cellulose acetate, non-degradable polyurethane, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulphonate, polyolefins, polyethylene oxide, polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polymethacrylate, hydroxypropyl methylcellulose (HPMC), ethyl cellulose (EC), hydroxypropyl cellulose (HPC), carboxymethyl cellulose, cyclodextrin, and copolymers of monomers forming the polymers. 
     
     
         20 . The method according to  claim 10 , wherein the liquid formulation is mixed with an active ingredient, the active ingredient comprising at least one of a protein/peptide medicine, a hormone, a hormone analogue, an enzyme, an enzyme inhibitor, a signal transduction protein or a portion thereof, an antibody or a portion thereof, a single-chain antibody, a binding protein or a binding domain thereof, an antigen, an adherent protein, a structural protein, a regulatory protein, a toxin protein, a cytokine, a transcription regulator, a blood coagulation factor, and a vaccine. 
     
     
         21 . The method according to  claim 20 , wherein the protein/peptide medicine comprises at least one of insulin, insulin-like growth factor 1 (IGF-1), growth hormone, erythropoietin, G-granulocyte-colony stimulating factors (CSFs), granulocyte/macrophage-colony stimulating factors (GM-CSFs), interferon alpha, interferon beta, interferon gamma, interleukin-1 alpha and beta, interleukin-3, interleukin-4, interleukin-6, interleukin-2, epidermal growth factors (EGFs), calcitonin, adrenocorticotropic hormone (ACTH), tumor necrosis factor (TNF), atobisban, buserelin, cetrorelix, deslorelin, desmopressin, dynorphin A (1-13), elcatonin, eleidosin, eptifibatide, growth hormone releasing hormone-II (GHRH-II), gonadorelin, goserelin, histrelin, leuprorelin, lypressin, octreotide, oxytocin, pitressin, secretin, sincalide, terlipressin, thymopentin, thymosine, triptorelin, bivalirudin, carbetocin, cyclosporine, exedine, lanreotide, luteinizing hormone-releasing hormone (LHRH), nafarelin, parathyroid hormone, pramlintide, enfuvirtide (T-20), thymalfasin, and ziconotide. 
     
     
         22 . The method according to  claim 18 , wherein the solvent comprises inorganic or organic solvents comprising distilled water (DI water), methanol, ehanol, chloroform dibutyl phthalate, dimethyl phthalate, ethyl lactate, glycerin), isopropyl alcohol, lactic acid, and propylene glycol.